Thyroid cancer is one of the most common endocrine malignancies with the most common clinical presentation being a thyroid nodule. It is believed that approximately 300,000 people per year in the United States have a clinical presentation of a thyroid nodule. Currently, the fine-needle aspiration biopsy (FNAB) is used in the initial work-up of a patient with a thyroid nodule to determine whether the thyroid nodule is malignant or benign.
Distinguishing between different thyroid neoplasms of benign follicular thyroid adenoma (FTA) and malignant follicular thyroid carcinoma (FTC) based on cytological examination is particularly challenging, due to the similar cytomorphological features of these tumors and often it requires histological examination of the tissue sample. Approximately 70% of the results from FNAB are classified as benign, 5% as malignant and the remaining as either indeterminate or suspicious (25%), in which case the patient should undergo diagnostic thyroidectomy in order to exclude malignancy. Up to 80% of the indeterminate cases are diagnosed as benign follicular thyroid adenoma, indicating removal of the thyroid was unnecessary. Complications from a thyroidectomy are rare (1-3%), but the procedure is expensive and there are lifelong consequences (e.g., thyroid hormone replacement and calcium deficiency treatment).
Therefore, in order to reduce the number of unnecessary operations there is a need for a diagnostic test that is more accurate than conventional methods.